[Remote] Global Vigilance Report Writer

Note: The job is a remote job and is open to candidates in USA. Advantage Technical is seeking a Global Product Monitoring Vigilance Report Writer who develops and maintains quality assurance methodologies for the medical-device industry. This role focuses on post-market vigilance and surveillance, requiring strong analytical judgment and collaboration with various teams to ensure compliance with regulatory standards.

Responsibilities

• Global Complaint Assessment — Assess, follow up, code, and perform vigilance activities for global complaints
• Vigilance Report Writing — Author, peer-review, and approve vigilance reports to ensure timely submission to regulatory authorities
• Operational Support — Support management in daily operations and ensure proper coding of complaints and reportable events
• Cross-Functional Collaboration — Work with engineering, investigation labs, medical teams, and other internal groups to review events, coding, and investigation results
• CAPA Participation — Contribute to departmental non-conformances escalated into the CAPA system
• Subject Matter Expertise — Serve as SME for post-market and complaint-handling regulatory questions
• Audit Support — Support internal and external audits and inspections
• Special Projects — Assist with assigned projects with minimal supervision
• Perform additional duties as required

Skills

• Bachelor's degree or equivalent combination of education and experience
• Demonstrated experience in medical‑device complaint triage and vigilance reporting or clinical experience in diabetes disease management or diabetes device support
• Strong proficiency with Microsoft Office and complaint database applications
• Effective verbal and written communication skills
• Ability to generate, verify, and maintain accurate records
• Strong analytical skills, attention to detail, and interpersonal skills
• Demonstrated ability to influence without authority
• Strong organizational skills with the ability to prioritize and escalate appropriately
• Solid understanding of formal medical‑device Quality Management Systems
• Direct experience writing and filing global vigilance reports
• Working knowledge of global, multi‑country vigilance reporting requirements and country‑specific differences
• Experience interacting directly with regulatory bodies (highly desired)
• BSN with diabetes experience, Registered Dietician, Licensed Dietician, or Diabetes Educator (preferred)

Company Overview

Company H1B Sponsorship